COVID-19 Trials of New Drugs and Treatments Led by UCSF Faculty at UCSF Fresno

Eyad Almasri, MD, (left) and Mohamed Fayed, MD (right)

UCSF faculty at UCSF Fresno are investigating potential therapies for the novel coronavirus (COVID-19).

Eyad Almasri, MD, a UCSF Fresno pulmonary disease specialist, is leading a study to expand the access of a promising drug, remdesivir, for COVID-19 patients with severe respiratory failure and who require mechanical ventilation support.

Remdesivir, a novel antiviral drug, was originally developed in 2002 for the first Severe Acute Respiratory Syndrome (SARS) and was tried on the Ebola virus in 2014. Worldwide clinical studies are showing promise with Gilead Sciences’ remdesivir for treatment of severe COVID-19 patients. And the federal Food and Drug Administration gave approval in April to UCSF Fresno for an exception to expand access to remdesivir for the medicine to be given to COVID-19 patients with severe symptoms. “This is not a randomized trial, where you could receive the actual medicine or a placebo,” Dr. Almasri said. “For people who meet certain criteria, they will be receiving this medicine if they sign a consent to be in the study.”

Across the country, patients had been placed on remdesivir under compassionate use, a process which allows seriously ill patients to have access to the drug that has not been FDA approved for COVID-19 symptoms. The extended use trial allows patients to receive the drug without having to go through the compassionate use approval process, which can take a few days, Dr. Almasri said. “We have a sense of urgency because we have patients who qualify and who could benefit from having access to the drug,” he said.”

At latest count, by the second week of the trial in mid-April, Dr. Almasri had placed seven patients on remdesivir. The first patient given the drug showed improvement after a week on the medicine and by the second week was breathing on his own without a ventilator, but Dr. Almasri cautioned against placing too much hope on the anecdotal evidence. The patient had extensive clinical support and might have improved without remdesivir, he said.

However, Dr. Almasri is hopeful that by late May there will be clinical evidence and the drug might become approved and available for use in the critically ill. “Everyone is hoping it is the drug that will save many of our patients,” he said, “but we have to approach this in a scientific way.”

In addition, UCSF Fresno was cleared to participate in a national randomized, double-blinded, placebo-controlled study to look at the efficacy and safety of hydroxychloroquine, an immunosuppressive drug and anti-parasite that can treat and prevent malaria and also treat lupus and arthritis. People with severe respiratory failure will be enrolled in the hydroxychloroquine study. “The patients are those who are on a ventilator and require a very high level of support,” Dr. Almasri said.

The study, Outcomes Related to COVID-19 Treated with Hydroxychloroquine Among In-patients with Symptomatic Disease, is also known as the ORCHID study. Hydroxychloroquine has received a lot of attention as a potential therapy for COVID-19. The UCSF Fresno study, headed up by Dr. Almasri, is funded by the National Institutes of Health (NIH) to evaluate hydroxychloroquine in a scientific way. “Hydroxychloroquine treatment for COVID-19 continues to be controversial, and we are approaching this in a very scientific way,” Dr. Almasri said.

UCSF Fresno also is participating in a multi-national trial for using extracorporeal membrane oxygenation (ECMO) in refractory respiratory failure due to COVID-19 infection. ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus for Acute Respiratory Disease (ECMOCard) is a prospective/retrospective multi-center short period incidence observational study of intensive care unit patients with COVID-19.

ECMO is a technique of providing extra respiratory support for patients who are failing conventional respiratory support. The UCSF Fresno study is being led by Mohamed Fayed, MD, a UCSF Fresno pulmonary and critical care disease specialist. The study is to determine the effect of ECMO on COVID-19 patients with severe refractory respiratory failure (failing mechanical ventilation), Dr. Fayed said.

UCSF Fresno has a dedicated team for ECMO to address the need for respiratory and/or cardiac ECMO support, he said.

As of April 20, one patient with severe COVID-associated pneumonia had been placed on ECMO and was responding well, Dr. Fayed said.

The study is worldwide and open-ended — and will continue as long as there are patients in need of the treatment, Dr. Fayed said.  “But we hope in a few months to have some outcome data.”

In addition to the remdesivir, hydroxychloroquine and ECMO studies, UCSF Fresno has other COVID-19 trials in the pipeline of the approval process, Dr. Almasri said. UCSF Fresno has been able to add studies with the cooperation of Community Medical Centers, he said.  “We need to ramp up our research very quickly to meet the demand of this pandemic.”